Duns Number:080897872
Device Description: CRF Radiofrequency Electrode
Catalog Number
CRF-U1540P
Brand Name
ElectrodeCRF
Version/Model Number
CRF-U1540P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192715,K192715
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
fcc9f1bf-1cd0-49ef-bc93-8d9306012768
Public Version Date
October 26, 2020
Public Version Number
1
DI Record Publish Date
October 16, 2020
Package DI Number
10811746032432
Quantity per Package
5
Contains DI Package
00811746032435
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 288 |